Description and Brand Names

US Brand Name

  1. Gabazolamine-05
  2. Niravam
  3. Xanax
  4. Xanax XR

Canadian Brand Name

  1. Alti-ALPRAZolam

Descriptions


Alprazolam is used to relieve symptoms of anxiety, including anxiety caused by depression. It is also used to treat panic disorder in some patients.

Alprazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet
  • Tablet, Disintegrating
  • Solution
  • Tablet, Extended Release

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of alprazolam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alprazolam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and kidney, liver, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Information about this alprazolam-oral-route
Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Delavirdine
  • Flumazenil
  • Itraconazole
  • Ketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Amobarbital
  • Benzhydrocodone
  • Boceprevir
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Ceritinib
  • Chloral Hydrate
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Cobicistat
  • Codeine
  • Conivaptan
  • Dantrolene
  • Dasabuvir
  • Digoxin
  • Domperidone
  • Doxylamine
  • Esketamine
  • Ethchlorvynol
  • Fentanyl
  • Flibanserin
  • Fluconazole
  • Fosnetupitant
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Idelalisib
  • Indinavir
  • Levorphanol
  • Lofexidine
  • Lopinavir
  • Loxapine
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Metoclopramide
  • Midazolam
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Periciazine
  • Phenobarbital
  • Piperaquine
  • Posaconazole
  • Primidone
  • Propofol
  • Ritonavir
  • Saquinavir
  • Scopolamine
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Telithromycin
  • Thiopental
  • Tramadol
  • Trazodone
  • Voriconazole
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amprenavir
  • Cimetidine
  • Desipramine
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Erythromycin
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fluoxetine
  • Imipramine
  • Kava
  • Levonorgestrel
  • Mestranol
  • Mifepristone
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Rifapentine
  • Roxithromycin
  • Sertraline
  • St John's Wort
  • Telaprevir
  • Theophylline
  • Troleandomycin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, history of or
  • Depression, or history of or
  • Drug abuse or dependence, history of or
  • Lung or breathing problems (eg, respiratory depression) or
  • Mania, or history of or
  • Mental health problems, or history of or
  • Seizures, or history of—Use with caution. May make these conditions worse.
  • Glaucoma, acute narrow angle—Should not be used in patients with this condition.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release tablet or tablet whole with a full glass of water. Do not break, crush, or chew it.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not remove the tablets from the bottle until you are ready to take it. Place the tablet immediately on the top of your tongue. It should melt quickly and be swallowed with saliva.

If you are using the oral liquid, measure the dose with a marked measuring spoon, oral syringe, or medicine cup.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For anxiety:
    • For oral dosage forms (solution, tablets, or orally disintegrating tablets):
      • Adults—At first, 0.25 to 0.5 milligram (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 mg per day.
      • Older adults—At first, 0.25 mg 2 or 3 times a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For panic disorder:
    • For oral dosage form (extended-release tablets):
      • Adults—At first, 0.5 to 1 milligram (mg) taken in the morning once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day.
      • Older adults—At first, 0.5 mg taken in the morning once a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage forms (solution, tablets, or orally disintegrating tablets):
      • Adults—At first, 0.5 milligram (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day.
      • Older adults—At first, 0.25 mg 2 or 3 times a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important to protect the orally disintegrating tablets from moisture. Remove and throw away any cotton packaging from the medicine bottle when you first use the medicine.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not take itraconazole (Sporanox®) or ketoconazole (Nizoral®) while you are using this medicine. Using any of them together with this medicine may increase the chance of serious side effects.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the above while you are using this medicine.

If you develop any unusual and strange thoughts or behavior while you are taking alprazolam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Alprazolam may cause some people, especially older persons, to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, sweating, tremors, vomiting, or unusual behavior.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Being forgetful
  2. changes in patterns and rhythms of speech
  3. clumsiness or unsteadiness
  4. difficulty with coordination
  5. discouragement
  6. drowsiness
  7. feeling sad or empty
  8. irritability
  9. lack of appetite
  10. lightheadedness
  11. loss of interest or pleasure
  12. relaxed and calm
  13. shakiness and unsteady walk
  14. sleepiness or unusual drowsiness
  15. slurred speech
  16. tiredness
  17. trouble concentrating
  18. trouble performing routine tasks
  19. trouble sleeping
  20. trouble speaking
  21. unsteadiness, trembling, or other problems with muscle control or coordination
  22. unusual tiredness or weakness

Less common

  1. Abdominal or stomach pain
  2. blurred vision
  3. body aches or pain
  4. burning, crawling, itching, numbness, prickling, "pins and needles, or tingling feelings
  5. changes in behavior
  6. chills
  7. clay-colored stools
  8. confusion about identity, place, and time
  9. cough
  10. dark urine
  11. decrease in frequency of urination
  12. decrease in urine volume
  13. diarrhea
  14. difficult or labored breathing
  15. difficulty in passing urine (dribbling)
  16. difficulty with concentration
  17. difficulty with moving
  18. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  19. dry mouth
  20. ear congestion
  21. environment seems unreal
  22. fainting
  23. fear or nervousness
  24. feeling of unreality
  25. feeling warm
  26. fever
  27. general feeling of discomfort or illness
  28. headache
  29. hyperventilation
  30. inability to move the eyes
  31. inability to sit still
  32. increased blinking or spasms of the eyelid
  33. irregular heartbeats
  34. itching or rash
  35. joint pain
  36. lack or loss of self-control
  37. loss of bladder control
  38. loss of coordination
  39. loss of memory
  40. loss of voice
  41. mood or mental changes
  42. muscle aching or cramping
  43. muscle pain or stiffness
  44. muscle weakness
  45. nasal congestion
  46. nausea
  47. need to keep moving
  48. painful urination
  49. problems with memory
  50. restlessness
  51. runny nose
  52. seeing, hearing, or feeling things that are not there
  53. seizures
  54. sense of detachment from self or body
  55. shaking
  56. shivering
  57. sneezing
  58. sore throat
  59. sticking out of the tongue
  60. sweating
  61. swollen joints
  62. talkativeness
  63. tightness in the chest
  64. trouble with balance
  65. twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  66. uncontrolled twisting movements of the neck, trunk, arms, or legs
  67. unpleasant breath odor
  68. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  69. unusual facial expressions
  70. unusually deep sleep
  71. unusually long duration of sleep
  72. vomiting of blood
  73. yellow eyes or skin

Rare

  1. Actions that are out of control
  2. attack, assault, or force
  3. chest pain
  4. continuing ringing or buzzing or other unexplained noise in the ears
  5. decreased awareness or responsiveness
  6. deep or fast breathing with dizziness
  7. ear pain
  8. false or unusual sense of well-being
  9. fast, irregular, pounding, or racing heartbeat or pulse
  10. feeling jittery
  11. feeling unusually cold
  12. generalized slowing of mental and physical activity
  13. hearing loss
  14. hoarseness
  15. lack of feeling or emotion
  16. loss of control of the legs
  17. loss of strength or energy
  18. nightmares
  19. numbness of the feet, hands, and around mouth
  20. severe sleepiness
  21. shakiness in the legs, arms, hands, or feet
  22. sleep talking
  23. swelling
  24. talking, feeling, and acting with excitement
  25. thoughts of killing oneself
  26. uncaring
  27. unusual weak feeling
  28. voice changes

Incidence not known

  1. General tiredness and weakness
  2. light-colored stools
  3. stomach pain, continuing
  4. upper right abdominal or stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Absent, missed, or irregular menstrual periods
  2. decreased appetite
  3. decreased interest in sexual intercourse
  4. decreased sexual performance or desire abnormal ejaculation
  5. difficulty having a bowel movement (stool)
  6. inability to have or keep an erection
  7. increased appetite
  8. increased in sexual ability, desire, drive, or performance
  9. increased interest in sexual intercourse
  10. increased weight
  11. loss in sexual ability, desire, drive, or performance
  12. stopping of menstrual bleeding
  13. watering of the mouth
  14. weight loss

Less common

  1. Abdominal or bloating and cramping
  2. blistering, crusting, irritation, itching, or reddening of the skin
  3. change in taste bad unusual or unpleasant (after) taste
  4. cracked, dry, or scaly skin
  5. cramps
  6. double vision
  7. feeling of warmth
  8. heavy bleeding
  9. menstrual changes
  10. pain
  11. pelvic pain
  12. redness of the face, neck, arms, and occasionally, upper chest
  13. seeing double
  14. sudden sweating
  15. unexplained runny nose or sneezing

Rare

  1. Acid or sour stomach
  2. belching
  3. bigger, dilated, or enlarged pupils (black part of the eye)
  4. change in color vision
  5. difficulty seeing at night
  6. feeling of constant movement of self or surroundings
  7. feeling of relaxation
  8. heartburn
  9. hives or welts
  10. increased sensitivity of the eyes to sunlight
  11. indigestion
  12. redness of the skin
  13. runny nose
  14. sensation of spinning
  15. stomach discomfort, upset, or pain
  16. stuffy nose

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. red, irritated eyes
  3. red skin lesions, often with a purple center
  4. sores, ulcers, or white spots in the mouth or on the lips
  5. swelling of the breasts or breast soreness in both females and males
  6. unexpected or excess milk flow from the breasts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.